Condition 1: Surgical site infection. Condition 2: exam for clinical exam program. Condition 3: internal infection. Infection following a procedure Encounter for examination for normal comparison and control in clinical research program Infection and inflammatory reaction due to internal fixation device
Conditions
Interventions
Intervention 1: Intervention group: All patients receive a standard preoperative dose of intravenous cefazolin prior to surgical incision. In the intervention group, cefazolin administration is contin
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with closed orthopedic fractures who are candidate for ORIF surgery. Age over 18 Provision of written informed consent by the patient or legal guardian for participation in the study
Exclusion criteria
Exclusion criteria: Presence of active infection or fever at the time of admission and prior to surgery Presence of an open wound (open fracture) concurrent with the closed fracture. History of hypersensitivity or allergic reaction to beta-lactam antibiotics. Use of antibiotics within the past two weeks prior to admission. Uncontrolled diabetes mellitus or severe immunocompromised state. End-Stage Renal Disease (ESRD) or severe hepatic impairment. Chronic use of immunosuppressive medications (e.g., high-dose corticosteroids). Trauma surgeries requiring extensive prosthesis implantation (e.g., emergency joint replacement). Patient withdrawal of consent at any stage of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Description: Incidence of surgical site infection (SSI), categorized as superficial (involving skin and subcutaneous tissue) or deep (involving fascia, muscle, or bone), based on standard criteria from the Centers for Disease Control and Prevention (CDC). Timepoint: Patients are followed up at three designated intervals: week two (day 14 post-surgery), week four (day 30 post-surgery), and week twelve (day 90 post-surgery). Method of measurement: A blinded assessor (a physician unaware of the patient's group allocation) examines the wound site for clinical signs including purulent drainage, localized pain, swelling, erythema, warmth, and fever. Paraclinical tests including white blood cell count (WBC), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) are evaluated, and wound culture is performed if drainage is present. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of postoperative hospital stay (in days), incidence of adverse drug reactions including phlebitis, gastrointestinal disturbances, and cutaneous hypersensitivity, readmission due to infection, and need for reoperation (debridement). Timepoint: Length of stay is recorded at discharge. Adverse reactions are assessed during hospitalization and at weeks 2, 4, and 12 follow-ups. Readmission and reoperation are recorded at any point during the 12-week follow-up period. Method of measurement: Length of stay is extracted from patient records. Adverse reactions are observed and documented by the ward nurse or treating physician. Readmission and reoperation are recorded via telephone follow-up, in-person visits, or hospital record review. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactPouya Azinmehr
Tabriz University of Medical Sciences
Outcome results
None listed